inforMED
MalfunctionNYU

PALINDROME

Received Apr 22, 2025 · Event occurred Apr 7, 2025

Report 21881353 · MDR key 21881353

Device

Generic name

Catheter, Hemodialysis, Implanted, Coated

Model number

8888123405P

Catalog number

8888123405P

Lot number

2412000239

Product problems

  • Failure to Advance
  • Defective Device

Patient

58 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

WHILE PERFORMING A HD [HEMODIALYSIS] CATHETER EXCHANGE IT WAS NOTICED THAT THE STIFFENERS INSIDE THE KIT DID NOT HAVE HOLES THAT ALLOW FOR A WIRE TO PASS THROUGH AND ADVANCE THE CATHETER INTO POSITION. ADDITIONAL SUPPLIES WERE NEEDED SO PROCEDURE WAS COMPLETED WITHOUT ISSUE. SUPPLY WAS A 23CM PALINDROME HEPARIN COATED HEMODIALYSIS CATHETER - REF#: 8888123405P - LOT#: 2412000239.